The following are ongoing research studies related to Type 1 Diabetes, in which individuals or families can participate. All studies conducted through the Max McGee Center are also listed on the ClinicalTrials.gov website.
Type 1 diabetes is a disease that happens when the pancreas (a gland behind the stomach) makes little or no insulin. Insulin is a hormone (chemical) released by a pancreatic beta cell which is needed for uptake of sugars (e.g. glucose, the main type of sugar in the blood) into body tissues for energy production. This energy fuels the body’s functions. Without insulin, too much glucose stays in the blood. Over time, increased glucose in the blood can lead to serious problems with the heart, kidneys, nerves, and eyes.
The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person’s own immune system, directed by genetic and environmental factors play a major role in its development. The Max McGee National Research Center for Juvenile Diabetes, affiliated with the Medical College of Wisconsin and Children’s Wisconsin, is using a genetic approach to try to better understand the step-by-step mechanisms that cause the destruction of the beta cells of the pancreas leading to diabetes. The more information scientists have, the better they can design studies to find possible treatment and prevention options for type 1 diabetes. But first, this study, Genetics of Autoimmunity in Type 1 Diabetes Mellitus may help us find more information about the disease.
Does someone in your family have type 1 diabetes?
If so, your family may be eligible to participate in our study to help us learn more about the causes of type 1 diabetes. If you would like to help, here’s how to get started:
We are looking for families which include a child with type 1 diabetes, brothers, sisters and parents. Adults with type 1 diabetes, their children and spouses are also needed.
If your family fits either description, you may complete our screening questionnaire. You can download, print and complete the paper copy. Type 1 Diabetes Family Study Screening Questionnaire (PDF)
Return completed form by mail or fax to:
Family Study Coordinator
Max McGee National Research Center for Juvenile Diabetes
Medical College of Wisconsin
8701 Watertown Plank Rd.
Milwaukee, WI 53226
(414) 955-6663 (fax)
Once we receive your completed form, a study coordinator will contact you and provide more information about study participation OR you may contact study coordinator at (414) 955-4903 or T1dinfo@mcw.edu
- A visit to Children’s Wisconsin by immediate family members to donate a blood sample for genetic analysis and measurement of immune system responses associated with type 1 diabetes
- Completion of a family medical history questionnaire
- Measurement of height and weight
- Possible follow-up: "at-risk" family members may be asked to give an additional blood sample once or twice a year for up to 10 years
If you don’t have type 1 diabetes in your family, you can still help.
We need healthy kids and adults to participate as “control subjects” or a comparison group. Control subjects provide an essential comparative sample to diabetic subjects. Answer the following questions to find out if you are eligible to participate:
- Are you older than age 39?
- Have you ever been told that you have diabetes of any kind?
- Do you have any close relatives (parents, brothers/sisters, aunts/uncles, nieces/nephews or grandparents) with type 1 diabetes?
- Do you have any other known autoimmune diseases or conditions?
(Includes: Addison’s Disease, Ankylosing Spondylitis (Marie-Strümpell Disease), Anterior Uveitis (Iritis), Autoimmune Polyendocrine Syndrome (APS), Autoimmune Thyroid Disease (such as Graves’ Disease or Hashimoto’s), Celiac Disease (gluten intolerance), Inflammatory Bowel Disease (Crohn’s Disease or Ulcerative Colitis), JRA (Juvenile Rheumatoid Arthritis), Multiple Sclerosis (MS), Myasthenia Gravis, Psoriasis, Rheumatoid Arthritis, Systemic Lupus.)
If you answered No to all of these questions, you may be eligible to participate.
Participation involves a visit to Children’s Wisconsin, answering some medical and family history questions and giving a blood sample of 50 ml (about 3 Tablespoons + 1 teaspoon). You will receive a gift certificate for your time and travel.
Please contact a study coordinator at (414) 955-8486 or firstname.lastname@example.org to participate.
Participation in Collaborative Studies
Evidence supports that most subjects who develop Type 1 diabetes (T1D) possess autoimmunity towards β-cells for years prior to clinical onset. Presently, it is impossible to precisely predict who will develop T1D or when they will clinically present. Siblings of T1D probands have an approximately 6% probability of progression to T1D. Therefore, the temporal analyses of samples from siblings of T1D probands is crucial for gaining an understanding of disease initiation and progression. The study of this population is also crucial to understanding mechanisms that prevent T1D progression within the context of high genetic risk. The Max McGee Research Center for Juvenile Diabetes Family Genetics Study is a longitudinal study aimed at gaining new insight into the mechanisms that govern progression to and protection from T1D progression. Subjects are enrolled through Children’s Wisconsin and return for yearly visits. The Children's Wisconsin Diabetes Clinic is a large program that cares for >1,600 pediatric diabetes patients on an annual basis; the majority of these (>91%) are T1D patients.
Presently the study includes approximately 500 families with T1D. In most cases, the parents, the pediatric new onset T1D proband, and the unaffected siblings have been enrolled. Eligible subjects are >2 years of age at the time of enrollment and are followed for a duration of up to 10 years. This study has been ongoing for nearly 15 years and to date we have collected samples and clinical data from >2,200 subjects, with longitudinal analyses of approximately 600 siblings. All subjects have been HLA typed by nucleotide sequencing of the second exons of HLA-DQA1 and HLA-DQB1. At each annual visit, serum, plasma, cryopreserved leukocytes, and DNA, have been collected and antibody titers have been measured (INS, ZnT8, GAD, IA2). Presently, the study encompasses >65 non-diabetic subjects that have seroconverted to autoantibody positivity and >500 persistently autoantibody negative subjects. To date, progression to T1D has been captured in 15 subjects. The study also includes age-, sex- and ethnically-matched unrelated healthy controls, as well as Type 2 diabetes controls.
We recognize that collaboration with investigators at other institutions is essential to our mission of understanding T1D pathogenesis and to our goal of identifying biomarkers of T1D progression or non-progression. As such, we have, and will continue to grant investigators at other institutions access to study samples through collaborative arrangements. Access is predicated on:
1) Scientific merit of the proposed analyses, in particular an assessment of the likelihood of scientific advancement over the risk of using samples that are difficult to replace;
2) sample availability and the ability to address the scientific question with appropriate control and statistical rigor;
3) an agreement that all analyses will be conducted in a blinded manner;
4) an understanding that data generated will be integrated with other analyses conducted on the same subjects with the objective of attaining a deeper understanding of progression/non-progression;
5) compliance with all institutional policies and IRB regulations at the collaborative sites involved.
Inquiries should be made directly with Martin Hessner, PhD (email@example.com). All collaborative arrangements will be reviewed/approved by a panel of McGee Center faculty.
Type 1 Diabetes TrialNet is a global network of researchers and immunology experts dedicated to the study, prevention, and early treatment of type 1 diabetes. It is supported by the Department of Health and Human Services National Institutes of Health, Juvenile Diabetes Research Foundation International, and the American Diabetes Association.
The Max McGee National Research Center for Juvenile Diabetes* is an Affiliate Site for the Natural History Study of the Development of Type 1 Diabetes. This study screens relatives of people with type 1 diabetes to find out if family members are at risk for developing diabetes.
The purpose of this study is to gain more information about how type 1 diabetes develops. Then studies can be designed for people who are at risk for developing type 1 diabetes or have just been told they have type 1 diabetes. The more information scientists have, the better they can design studies to find possible treatment and prevention options for type 1 diabetes. But first, the Natural History Study may help find more information about the disease.
TrialNet also has prevention studies and intervention studies. If you are enrolled in the Natural History Study and learn you are at risk for developing type 1 diabetes, you may qualify to be enrolled in a prevention study. If you develop diabetes during the study, you may qualify for an intervention study.
You may be able to take part in this study if you are:
- Between 1 and 45 years old and have a brother, sister, child or parent who has been diagnosed with type 1 diabetes
- or -
- Between 1 and 20 years old and have a cousin, niece, nephew, aunt, uncle, half sibling, or grandparent who has been diagnosed with type 1 diabetes
You may not be able to participate if you:
- Have diabetes already
- Have a previous history of being treated with insulin or oral diabetes medications
- Are currently using systemic immunosuppressive agents (topical or inhaled agents are acceptable
- Have any known serious diseases
You may contact the study coordinator for more information:
(414) 955-4903 | T1dinfo@mcw.edu
TrialNet Study Coordinator
Max McGee National Research Center for Juvenile Diabetes
Children’s Wisconsin/ Medical College of Wisconsin
8701 Watertown Plank Rd.
Milwaukee, WI 53226
- A visit to Children’s Wisconsin to donate a blood sample which will be screened for diabetes-related antibodies
- Answering a few medical history questions
- Possible follow-up: individuals with a positive antibody result may be offered further testing to determine their risk of developing diabetes over the next 5 years. You would need to give additional permission to participate in the next stage of testing.
- National Institute of Diabetes & Digestive & Kidney Disease (NIDDK)
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Child Health and Human Development (NICHD)
- National Center for Research Resources (NCRR)
- Juvenile Diabetes Research Foundation International (JDRF)
- American Diabetes Association (ADA)
*The Max McGee National Research Center for Juvenile Diabetes is affiliated with the Medical College of Wisconsin and Children’s Wisconsin.
Researchers from Indiana University are testing if DFMO (also called eflornithine) may be of benefit in people with newly diagnosed Type 1 diabetes (T1D). This study is comparing measures of beta cell stress in people who take active drug with those who get placebo (look alike that contains no medicine). This study will also examine whether DFMO slows destruction of beta cells and the safety of DFMO.
DFMO is a drug that has been approved for use before in other diseases in intravenous (given as an infusion) or cream forms. It is also being used in pill form in other research studies for cancer prevention and therapy. This will be the first study of its use for diabetes.
Why join our study?
People recently diagnosed with T1D often are still making some insulin of their own. Studies have shown that people who continue to make their own insulin have less trouble with low blood glucoses and fewer complications from their diabetes than people who no longer make any insulin. We hope giving medicines to affect beta cell stress soon after diabetes is diagnosed may be able to stop or delay beta cell destruction, resulting in better blood sugar control.
Who can be in the DFMO study?
You can be screened for our study, if:
- You are 12-40 years old
- You were diagnosed with T1D within the past 6 months.
What will study participants be asked to do?
If you are in this study, you will come for 5 study visits over 8 months. For three months you will take either active drug or placebo as pill(s) once or twice per day. Neither you nor your study team will know which you are getting.
During the study you will continue to manage your diabetes with the help of your regular diabetes team. All study participants will still need to take insulin injections and actively manage their diabetes.
While there is no guarantee of any health benefit, you will work closely with our diabetes care team.
Beta Cells in Type 1 Diabetes
Beta cell destruction begins years before people show any diabetes symptoms. By the time T1D is diagnosed clinically, most beta cells have been destroyed. The ones that are left are often “stressed” and release abnormal insulin fragments. A few years after diagnosis, most persons with T1D are no longer making their own insulin.
This study is looking at whether we can reduce this stress that the beta cells are experiencing.
This study is funded by the JDRF.
(414) 955-8486 | firstname.lastname@example.org
We would like to invite your child to take part in a research study that is looking at different factors that determine what happens to a person's own insulin production after they are diagnosed with Type 1 diabetes. We hope this research will allow us to take better care of people with Type 1 diabetes and develop new treatments to prevent or stop diabetes. This study is sponsored by the Juvenile Diabetes Research Foundation (JDRF).
If your child is in this study, they will come to the Children's Wisconsin research clinic in Milwaukee for five study visits over two years. Your child will complete a mixed meal tolerance test (MMTT) during the study visits. MMTTs involve not eating or drinking anything overnight, then drinking a milkshake-type drink, with blood samples drawn from an IV (a thin, flexible plastic tube in a vein in the arm) over two hours. Because we use an IV, your child will not need to be “poked” each time the blood is drawn during the MMTT. The IV will be removed when the MMTT is done. Participation will also involve answering questions about your child’s typical diet, and collection of stool samples. Each visit will take up to four hours to complete. You will speak to a member of the study team about the study and be asked to sign a consent form before your child begins the study. Your child will be compensated for their time. We will also work to coordinate your child’s study and clinic visits to reduce the number of trips to CHW.
If you would like more information or you would like to have your child join this study, Development of Predictive Biomarkers for the Rate of C-peptide Decline in Persons with Recent Onset Type 1 Diabetes, please contact a study coordinator at (414) 955-4903 or email@example.com.
We would like to invite your child to take part in a research study that is looking at the effect of a diet on diabetes susceptibility. We are studying the immune systems of siblings of people with Type 1 diabetes, who do not have the condition themselves. We hope this research will help us understand ways that we can slow down the process that leads to the development of Type 1 diabetes. This study is sponsored by the American Diabetes Association (ADA).
If your child is in this study, they will be put on a gluten and Amalyse Trypsin Inhibitor (ATI) free diet for four weeks. Gluten and ATI are proteins found in grains. You will be given education about this diet as well as a stipend to off-set the cost of the diet. Your child will resume their normal diet after the four weeks are done.
Participation will involve four visits to the Children's Wisconsin research unit. Two of the visits will occur before the start of the diet and two will occur after. Participation involves a blood collection, answering questions about your child's typical diet, education on the gluten and ATI free diet, and collection of stool samples. You will speak to a member of the study team about the study and be asked to sign a consent form before your child begins the study. Your child will be compensated for their time.
If you would like more information or you would like to have your child join this study, Gluten and Amylase Trypsin Inhibitors as Nutritional Contributors to Type 1 Diabetes Susceptibility, please contact a study coordinator at (414) 955-4903 or firstname.lastname@example.org.
We would like to invite your child to take part in a research study looking at how the digestive and immune systems are affected by a probiotic. We want to see if taking a probiotic could help lower someone’s chances of developing Type 1 diabetes. To do this, we will place healthy children with a family history of type 1 diabetes on a six week course of probiotic supplementation. This study is sponsored by the Children’s Research Institute (CRI) at Children’s Wisconsin.
If your child is in this study, they will come to the Children’s Wisconsin research clinic in Milwaukee for 3 study visits, each lasting between 1-2 hours. The first visit will involve an exam by a study doctor and answering questions about your child’s typical diet. At the second visit, your child will be given a probiotic, which they will take by mouth 1 or 2 times a day for 6 weeks. During the second and third visits, your child will also have blood collected from a vein in the arm and return a stool sample collected at home before the visit. You will speak to a member of the study team about the study and be asked to sign a consent form before your child begins the study. Your child will be compensated for their time.
If you would like more information or you would like to have your child join this study, Modulation of Type 1 Diabetes Susceptibility through VSL#3 Probiotic-induced Alterations in the Intestinal Microbiota, please contact a study coordinator at (414) 955-4903 or email@example.com.
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